Early Detection of Pancreatic Cancer in Patients With Papillary and Mucinous Intracanal Tumours of the Pancreas Papillary and Mucinous Tumours of the Pancreas

Not Applicable

Not yet recruiting

• Conditions: PAPILLARY AND MUCINOUS INTRACANAL TUMORS OF THE PANCREAS
• Interventions: Other: blood sampling at inclusion, 6 months, 1 year and 2 years. Tumor and intracystic fluid samples are taken only if a biopsy is planned following MRI results.

• Registration Number: NCT06000553
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

This trial is a prospective, exploratory and descriptive study. The primary objective is to identify early diagnostic biomarkers in patients with TIPMP based on the analysis of Treg lymphocyte subpopulations and epigenetic signatures, and the secondary objective is to characterize the biological processes underlying the transformation of a pre-neoplastic lesion into established ADPC.

Detailed Description

To meet the objectives of the study, patients will have blood samples taken at the time of their TIPMP monitoring, i.e. at inclusion, 6 months, 1 year and 2 years. If echo-endoscopy is performed during MRI monitoring of their disease, and a sample is taken as part of the treatment, a tumor sample and an intra-cystic fluid sample will be collected as part of the protocol.

Study Timeline

• Study First Submitted: 2023-06-13
• Status Verified: 2023-07
• Study First Submitted QC: 2023-08-17
• Last Update Submitted: 2023-08-17
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21
• Study Start: 2023-10-30
• Primary Completion: 2028-10-30
• Study Completion: 2028-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Age over 18
2. Patient with intermediate-risk or high-risk TIPMP according to the European Study Group on Cystic Tumours of the Pancreas (3)
3. Signed consent to participate
4. Affiliation with a social security scheme, or beneficiary of such a scheme.

Exclusion Criteria

1. Pregnant or breast-feeding woman
2. Person in an emergency situation or unable to give consent.
3. Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),
4. Unable to undergo medical follow-up for geographical, social or psychological reasons.
5. contraindication to MRI.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
collection of blood and tumor samples	blood sampling at inclusion, 6 months, 1 year and 2 years. Tumor and intracystic fluid samples are taken only if a biopsy is planned following MRI results.	-

Primary Outcome Measures

Name	Time	Method
the aim is to search for immune and metabolic abnormalities in patients with at-risk TIPMP in the blood or by echo-endoscopic sampling, then compare and combine them with the criteria used in clinical practice.	for two years	Biomarkers will be studied to determine whether those selected have been effective in identifying patients with pancreatic adenocarcinoma.